A dangerous allergy to change

Behind the EpiPen is an odd saga which not only illustrates some of the paradoxes of American healthcare but also stirs up strong emotions

A few years ago, Heather Bresch, the sparky chief executive of Mylan, a generic and speciality drugs company, visited Disneyland with her four children. As she entered the theme park, what caught her eye was not Mickey Mouse but a collection of “defibrillator stations” tucked between the rides, ready to provide emergency resuscitation to anybody who suffered a heart attack.

It sparked, Bresch says, an “Aha!” moment. Mylan owns the patent on a device known as an EpiPen, a retractable syringe that administers epinephrine to anyone suffering a severe allergic reaction. Until recently, these were not marketed aggressively. But as Bresch looked at those defibrillators, she wondered why EpiPens were not there, too? Both devices only work if they are used quickly, so why not have anti-allergy devices placed everywhere, ready for easy use if a child reacts to nuts, a bee sting or anything else? It is an intriguing question – and not just for Mylan, which is trying to make a profit by flogging those EpiPens. For behind this piece of plastic there is an odd saga which not only illustrates some of the paradoxes of American healthcare, but also stirs up strong emotions, particularly from the parents of allergy-prone kids.

Gillian Tett

The issue at stake revolves around the degree to which the US government is willing to let its citizens buy and administer life-saving medicine without state controls. At first glance, the EpiPen might look like a device that conforms perfectly to libertarian ideals. It is deliberately designed to be simple enough for even a child to use unaided (it is based on a kit created by the US military in the 1960s to enable soldiers to inject themselves against nerve agent poisoning). And the dose of epinephrine – or adrenaline – dispensed by the EpiPen is so small that, while it is enough to halt allergic reactions, the only likely side effect is a raised heartbeat.

Nevertheless, when the device went on the market a few years ago, US regulators stipulated that it could only be made available on prescription and administered to a specific patient. Officially, this is to prevent abuse and curb side effects. However, some citizen groups blame it on the conservative, protectionist instincts of the medical profession. Either way, around 1.7 million Americans have now received EpiPens, via prescription, and many of these have reason to be grateful: on YouTube or Facebook, for example, there are now dozens of moving testimonies from people who say that an EpiPen has saved their life.

But Bresch thinks there is much further to go. And while Mylan’s own interest is clearly commercial, it is hard to disagree. According to the Food Allergy & Anaphylaxis Network, about 4 per cent of American adults and 8 per cent of children currently have serious allergies – an 18 per cent rise in the past decade. However, at least one in four children who suffer a serious allergy attack has never had a problem before. Nor have many adults. Thus, only around 7 per cent of the people who are at risk of an allergic reaction are now thought to hold EpiPens, either because they have never bothered to get a prescription, were unaware of their risk, or could not afford the $100 price-tag. And even people who have prescriptions sometimes leave their EpiPens behind.

Earlier this year a seven-year-old girl in Virginia went into shock when she ate a peanut during a school break. Although the school held EpiPens for other children, it was not allowed to administer one to her, since she was not “named” on any of the prescriptions. Tragically, the child died. And this is not an isolated case: estimates range between 200 and 1,500 people are thought to die in America each year from similar allergic reactions which could have been reversed with an EpiPen.

Some change is now underway. Last year, the Illinois Senate passed a law which permits schools to stock EpiPens, and some other states are considering doing the same. Two senators – Dick Durbin and Mark Kirk – are pushing a bipartisan federal bill, too. The drugs company Sanofi is developing a competing device, and as awareness of the allergy threat grows, a “grey” market for EpiPens is springing up, as anxious parents persuade doctors to write speculative prescriptions. And, of course, Bresch continues to lobby for deregulation – inspired by those Disney defibrillators. It is not, however, an easy fight.

The reason why defibrillators have become ubiquitous today is that President Bill Clinton passed a so-called “Good Samaritan” law in 2000 which allowed anybody to administer these devices without being sued. However, he only did that because a powerful lobby of middle-aged voices was demanding change, due to concern about heart attacks. But it is unclear whether powerful voters and political backers care as much about allergies. And, of course, Congress is badly gridlocked.

In the last resort, in other words, it is politics – not medicine – that will decide whether Disney (or anywhere else) ever stocks EpiPens. Parents, you have been warned.